A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact on the safety of the subjects or the scientific value of the study.
Non-substantial amendment
Amendments may be made to the conduct of a clinical trial. These are not substantial if they are not likely to have an impact on the safety of the trial subjects, on the interpretation of the scientific documents in support of the conduct of the trial, or if they are not otherwise significant. It is up to the sponsor to assess the substantiality of the amendment.
Non-substantial amendment in the European Union
– The EU directive does not require notification to the competent authorities (CAs)/ethics committees (ECs) of a non-substantial amendment, but in rare cases, CAs/ECs require to be notified for their information. Non-substantial amendments can be implemented right away by the sponsor and should always be documented; if not notified, they should be included in the next substantial amendments submitted to the CAs/ECs.
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